Prospective randomized trial of ketorolac after congenital heart surgery

Objective: Ketorolac is a potent nonsteroidal analgesic agent used to treat postoperative pain. It produces excellent analgesia without the sedating side effects of opioid analgesics. Routine use of ketorolac after cardiac surgery is limited by concerns of bleeding complications. The purpose of this study was to evaluate the risk of bleeding complications of ketorolac for treatment of pain after congenital heart surgery in infants and children. Design: Prospective randomized, controlled trial. Setting: Pediatric cardiac intensive care unit in tertiary teaching hospital. Participants: Seventy infants and children, median age 10 months (range 2.5-174), who underwent congenital heart surgery requiring cardiopulmonary bypass were randomized in the trial. Intervention: Pain control was performed with ketorolac and opioid analgesics in one arm of the study and opioid analgesics alone in the other arm. Outcome Measures: The main outcome evaluated was bleeding complications measured by chest-tube drainage and wound and gastrointestinal bleeding. Results: Thirty-five patients were randomized to each treatment arm. In the ketorolac group, the median chest-tube drainage was 13.3 (range 4-22) mL/kg/d, no patient had significant wound bleeding, and 1 (0.03%) patient had gastrointestinal bleeding. In the control group, the median chest-tube drainage was 16.5 (range 3-24) mL/kg/d, 1 (0.03%) patient had wound bleeding, and no patient had gastrointestinal bleeding. Conclusion: Ketorolac can be used to treat pain after congenital heart surgery without an increased risk of bleeding complications. (C) 2004 Elsevier Inc. All rights reserved.